Kornimate/medical-research-clean huggingface dataset:
efficacy of angiographic embolization vs non-embolization of moderate/poor vascularized vertebral metastases on intraoperative bleeding during surgery decompression and vertebral stabilization.

Conditions: Spine Metastasis; Early Goal Directed Therapy; Embolization, Therapeutic; Blood Loss

Summary: although angiographic embolization has been introduced for preoperative management of spine metastases in 1975 and is suggested today by many authors in the management of such pathologies, it needs to be confirmed by rct. it is a minimally invasive procedure, not free from complications. the recent meta-analyzes, due to the limited number of patients included are not exhaustive about the effectiveness of embolization in the reduction of the intraoperative bleeding, especially in the context of poor / moderate metastasis vascularization. we want to evaluate the efficacy of preoperative angiographic embolization of intermediate / poor vascularized spine metastases in reducing intraoperative blood loss during excision surgery.


Eligibility criteria:
inclusion criteria: * male, female aged 18 years and 75 years * prognosis \>6 months (tokuhashi score ≤ 11) * patients with lesions with moderate vascularization (grade 2) * time between embolization and intervention \>/= 48-72 h exclusion criteria: * congenital and iatrogenic hemocoagulative disorders (pt inr\> 1.5, aptt ratio\> 1.25 with documented coagulation factor deficiency, plt \< 80,000 / microl or known coagulation pathologies); * renal failure (creatinine ≥ 1.2); * mdc iodized allergy; * pregnancy / lactation; * chronic ischemic heart disease; * precluded arterial access by angiography; * indication to emergency surgery; * time between embolization and surgery\> 72 h; * refusal by the patient.

Keywords: embolization blood loss early goal directed therapy spine metastasis
the effect of intramyometrial injection of terlipressin versus carbitocin on hemoglobin and blood loss during open myomectomy operations without using haemostatic tourniquets

Conditions: Myoma

Summary: for gynecologists, reaching a conclusion about the efficacy of intramyometrial terlipressin injection versus intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. besides enriching the clinical evidence in open myomectomy without using haemostatic tourniquets. for society, our conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. moreover, providing more information for women undergoing open myomectomy without using haemostatic tourniquets.

this study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at wael elbanna clinic and the nrc site. the study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. data will be pooled and presented in aggregate, without the identification of individual subjects. the study materials that will be used will include blood tests and ultrasound. the study will involve three study arms: * arm 1: intramyometrial terlipressin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets * arm 2: intramyometrial carbetocin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets * arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure without using haemostatic tourniquets subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. women will be randomized to one of the three arms using a computergenerated randomization table with a 1:1:1 group allocation

Eligibility criteria:
inclusion criteri * women aged 16-45 yearsappropriate medical status for open surgery (largest myoma size from 4 cm up to 20 cm) * baseline hemoglobin ≥9 g/dl * no contra-indications to the use of glyopressin or carbitocin * myoma-related symptoms, such as pelvic pressure or pain,menorrhagia, or infertility * not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks) exclusion criteria * open myomectomy using mechanical tourniquet * previous myomectomy * history of bleeding disorders * concurrent anticoagulation therapy * history of uncontrolled ischaemic heart disease * any pelvic abnormalities requiring concomitant surgery * treatment with a gnrh agonist or ulipristal acetate within three months preceding surgery * inability to understand and provide written informed consent
follow-up study of covid-19 patients in the district konstanz

Conditions: SARS-CoV-2 Positive Patients

Summary: this is a prospective single-center study for the follow-up of sars-cov-2 positive patients in the district of konstanz (lkn). as part of the coronavirus pandemic, patients with sars-cov-2 infection are currently being treated in the clinics of the lkn's health network at the singen (hegau-bodensee clinic) and konstanz (konstanz clinic) locations. so far, there is little data on the long-term effects of sars-cov-2 infection. as part of this study, the disease progression of these patients will be monitored. study objective: prospective, controlled follow-up observation of sars-cov-2 positive patients regarding their secondary diseases and quality of life.


Eligibility criteria:
inclusion criteria: a inclusion criteria of sars-cov-2 positive patients: patient must meet all of the following criteria. 1. positive test for sars-cov-2 by pcr 2. signed informed consent and privacy policy b inclusion criteria of the control group: volunteer must meet all of the following criteria. 1. no contact to sars-cov-2 positive patients 2. negative sars-cov-2 antibody test 3. signed informed consent and privacy policy exclusion criteria: patient/volunteer will be excluded if any of the following conditions apply: 1. patient/volunteer age \< 18 years 2. patient/volunteer who are unable to read the information and understand the nature of the study 3. patient/volunteer participate in any other clinical study

Keywords: covid-19 virus disease sars-cov-2 hospitalization quality of life eq-5d-5l cardiomyopathy, kansas city (kccq-12)
calcium over postprandial effects of fatty meal on metabolism, blood pressure, oxidative stress, endothelial function.

Conditions: Obesity

Summary: the purpose of the study is to investigate calcium acute influence over the postprandial effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure, oxidative stress, and endothelial function in obese women.

studies suggest that dietary calcium intake is inversely associated with cardiovascular disease, but supplementary calcium appears to be associated with raised risk of cardiovascular events. fatty meals lead to oxidative and inflammation which seems to interfere in postprandial dismetabolism, a predictor of cardiovascular events. to investigate calcium acute influence over the postprandial effects of a fatty meal a crossover, controlled, and randomized clinical trial will be conducted with obese adult women who will be randomized into one of the three interventions, characterized by a fatty meal with different contents of calcium: low calcium (40 mg), high dietary calcium (540 mg from non-fat milk), and high supplementary calcium (540 mg from calcium carbonate). each participant will receive all three meals and one of them every week. before meals' intake blood sample will be collected and endothelial function assess will be performed. participants will eat the specific meal and endothelial function will be assessed again after 120 minutes. blood sample collections will be repeated every 60 minutes after meal's intake to perform latter biochemical analyzes to determine: 8-isoprostane levels, to assess oxidative stress status; triglycerides; glucose; insulin; and serum calcium. blood pressure will be continuously assessed during 25 minutes before meals' intake and during 2 hours after it.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) greater than or equal to 30 kg/m2 and below 40 kg/m2 * habitual dietary calcium intake below 500 mg per day exclusion criteria: * smoking * dietary supplements or drugs that could interfere with body weight, metabolic profile and blood pressure * diabetes * thyroid dysfunction * hypertension * angina pectoris * heart kidney or liver failure * intestinal malabsorption * acute or chronic inflammation * hiv infection * autoimmune diseases * cancer * chronic obstructive pulmonary disease * dyslipidemia with indication for drug treatment * history of myocardial infarction or stroke * pregnancy and lactation * menopause

Keywords: acute calcium dietary calcium supplementary calcium postprandial metabolism
biomarkers and therapeutic modelisation in heart failure

Conditions: Heart Failure

Summary: the telemonitoring systems for congestive hf did not yet prove their efficacy despite initial encouraging results. decongestion is one of the main objectives in congestive hf, but an appropriate titration of diuretics is warranted, since long-term use of diuretics was consistently found associated with adverse outcomes. the investigators showed (rossignol et al., jacc 2011, circulation 2012) that the aldosterone antagonist eplerenone has diuretic effects, as assessed by an estimated plasma volume depletion, in addition to potassium-sparing properties, independently from renal function variations. these three parameters were independently associated with patient outcomes and may therefore be potential monitoring/and therapeutic targets in patients with congestive hf. main objective : to assess the variations of estimated plasma volume, serum potassium and estimated glomerular filtration rate after an hospitalization for decompensated hf, by using a home-based finger capillary punction for 5 consecutive days per week during the two months postdischarge, using an approved dedicated device (abott istat). secondary objectives : 1. to assess the correlations between plasma volume, serum potassium and estimated glomerular filtration rate variations (as measured by istat, and by a weekly venous punction) and body weight, home blood pressure measurement, dyspnea self assessment variations. 2. bio banking (serum, plasma, urine) for further biomarker studies, one a weekly basis


Eligibility criteria:
inclusion criteria: * 18 years old or over * patients with heart failure and fe ≤ 45% hospitalized for decompensated heart failure exclusion criteria: * gfr \< 30 ml/min/1.73 m2 as estimated by the abbreviated mdrd formula * pregnancy and lactation * participation in other investigational trials

Keywords: heart failure telemonitoring systems for congestive hf biomarkers
management of ldl-cholesterol with inclisiran + usual care compared to usual care alone in participants with a recent acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to study the effectiveness of implementation of a systematic ldl-c management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (acs) and have an increased ldl-cholesterol (≥70 mg/dl) despite being treated with a statin drug.

the purpose of this study is to assess the effect on ldl-c of implementation of a systematic ldl-c management care pathway that includes initiation of inclisiran compared to usual care without inclisiran in participants with a recent hospitalization (inpatient/outpatient) for an acute coronary syndrome (acs) with ldl-cholesterol ≥70 mg/dl despite receiving statin therapy.

Eligibility criteria:
inclusion criteria: * recent acute coronary syndrome (in-patient/out-patient) within 5 weeks of screening * serum ldl-c ≥70 mg/dl or non-hdl-c ≥100 mg/dl * fasting triglycerides \<4.52 mmol/l (\<400 mg/dl) at screening * calculated glomerular filtration rate \>20 ml/min by estimated glomerular filtration rate (egfr) * participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an acs. statin intolerant participants are eligible if they had intolerable side effects on at least 2 different statins, including one at the lowest standard dose exclusion criteria: * new york heart association (nyha) class iiib or iv heart failure or last known left ventricular ejection fraction \<25%. * significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening. * severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years. * treatment with other investigational products or devices within 30 days or five half˗lives of the screening visit, whichever is longer. * planned use of other investigational products or devices during the course of the study. * treatment with monoclonal antibodies directed towards pcsk9 within 90 days of screening. * recurrent acs event within 2 weeks prior to randomization. * coronary angiography and revascularization procedure (percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg) surgery) performed within 2 weeks prior to the randomization visit or planned after randomization.

Keywords: hyperlipidemia atherosclerotic cardiovascular disease hypercholesterolemia lipid lowering therapies
evaluation of a night spectacle correction concerning an improvement of mesopic vision quality

Conditions: Myopia-Night Blindness

Summary: reduced quality of vision and glare in twilight or night are frequently mentioned complaints within the optometric examination. a reason for these problems could be a myopic refractive shift in dark light conditions, commonly known as night myopia or twilight myopia. the aim of this study was to investigate whether quality of vision in twilight or night could be improved by a spectacle correction optimized for mesopic light conditions. moreover, objective refraction in large pupils measured by aberrometry was compared to subjective mesopic refraction.

after obtaining informed consent, aberrometry was performed in a darkened room (0.1 lux). subjective photopic refraction and visual acuity were measured before light was turned off and mesopic refraction was obtained after a dark adaptation period of five minutes. finally, frames and lenses were fitted by a centration system. lens grinding was executed centralized by a grinding workshop. in the course of this study, subjects were randomly assigned to wear two glasses double-masked in turn. one with photopic subjective refraction data and another with mesopic subjective refraction data. both were worn for 14 ± 2 days each. follow up 1: after two weeks, participants were asked for their subjective experiences with the first correction by a visual analogue scale questionnaire. after the evaluation, glasses were changed. follow up 2: two weeks later, subjective experiences were evaluated again. after visual analogue scale questionnaire, subjects were asked to compare the two glasses concerning quality of mesopic vision and subjective safety level during night driving.

Eligibility criteria:
inclusion criteria: * visual acuity at least 0.8 (5/6) * binocular vision exclusion criteria: * refraction more than sph +/- 6 d and cyl 2 d * difference between habitual correction and actual refraction more than 0.5 d * medication with an influence on visual system * disease or eye disease with an effect on the visual system * pregnancy or other hormonal variances * influence of drugs * mental handicap

Keywords: night vision mesopic visual acuity aberrometry mesopic spectacle correction night myopia
air polishing effect on biological, clinical and patient-reported experience among epileptic and non-epileptic children

Conditions: Epilepsy; Gingivitis

Summary: in epileptic and non epileptic children, the full dentition of each patient was split into four quadrants, starting from the upper right quadrant (1) and moving clockwise until the lower right quadrant (4). bundled into two groups: quadrant (1+3) vs. (2+4). after randomization, each of these pairs of quadrants had the same treatment modality; test quadrants received treatment with airflow to remove soft biofilm, and ultrasonic scaler for areas with calculus deposits, and control quadrants were treated with conventional rubber cup polishing to remove soft biofilm and ultrasonic scaler for calculus deposits.

the treatment of each quadrant was administered sequentially, beginning with the upper right quadrant. treatment duration was measured in seconds from the start of treatment in each quadrant until the removal of all disclosed biofilm and calculus. this process was repeated for each quadrant individually. and intra-oral photographs were taken before, immediately after treatment, and at follow-up time. conventional treatment was conducted after biofilm disclosure by a rubber cup and prophylaxis paste spearmint (kemdent works, purton. swindon, wiltshire. sn5 4ht, uk). the power setting was between 70% and 100%. the rubber cup was used until all biofilm was removed, then, if present, calculus was removed by electro medical systems (ems) ultrasonic scaler with a power setting between 3-6 on the airflow control panel. for airflow, treatment was conducted after biofilm disclosure. the powder chamber of the air polishing device was filled with low-abrasive erythritol powder, according to the manufacturer's instructions. the tip of the handpiece was positioned at an angle of 70° to the surface of the tooth to be polished at 3 mm from the tooth surface. once activated, a non-stop movement from mesial to distal and distal to mesial in a smiley face shape starting from the gingival sulcus and moving upwards coronally to the incisal to cover the entire clinical crown was performed, with a power setting ranging from 3-6 on the control panel of the airflow device. ems ultrasonic scaler was used to remove calculus if present with a power ranging from 3-6.

Eligibility criteria:
inclusion criteria: * children aged 5 to 15 years with epilepsy * on anti-epileptic drugs (aed) for at least 3 months * periodontal pockets depths not exceeding 3mm * full-mouth plaque scores over 50%, and having 5 teeth per quadrant. * the non-epileptic group included healthy non-epileptic children meeting similar criteria for age, periodontal health, and plaque scores exclusion criteria: * coexisting neurological illnesses other than epilepsy, medical conditions impacting oral health, periodontitis, asthma, swallowing difficulties, intellectual disabilities, and non-ambulatory status

Keywords: air polishing airflow erythritol oral health of special healthcare needs children
"resilient caregivers" - a resilience-based intervention for distressed partner cancer caregivers

Conditions: Distress, Emotional

Summary: the objective of this study is to develop and test the effectiveness of a resilience-based intervention for distressed partner caregivers of cancer patients in reducing symptoms of anxiety, depression and distress, while improving quality of life and resilience (meta-reflective skill, values clarification and coping strategies).

informal caregivers of cancer patients often experience significant psychological distress, which may even exceed that of the patient's. partners or spouses are typically the most important caregiver and emotional support person for the cancer patient, but there is a lack of psychological interventions that specifically target caregiving partners. "resilient caregivers" is a novel 7-session group-based program aimed specifically at improving the participant's ability to cope with the stresses of being a partner to a cancer patient. in this randomized trial, the investigators aim to assess the potential efficacy of this program in improving the caregiver's resilience and quality of life, as well as reducing symptoms of anxiety, depression and distress. outcomes will be assessed at baseline and at 3, 6 and 12-months follow-up.

Eligibility criteria:
inclusion criteria: * partner/spouse to a patient diagnosed with stage i-iii cancer and receiving cancer treatment at herlev hospital * patient performance status 1 or 2 * distress thermometer score \> 4 * able to speak and understand danish * has given written informed consent to participate in the study exclusion criteria: * being a cancer patient * has untreated psychopathology or physical impairment that may prevent attendance and participation in the study * active substance abuse

Keywords: cancer caregivers distress anxiety resilience coping
peri kasai portoenterostomy anchoring of the jejunal loop

Conditions: Biliary Atresia

Summary: the study of the effect o the hanging of the jejunal loop to the peri kpe glisson capsule on the rate of bile drainage and requirement of liver transplantation

to evaluate the effect of anchoring jejunal loop to glisson capsule of liver after completion of modified kasai portoenterostomy (kpe) on the frequency of attacks of cholangitis and the overall incidence of native liver survival. methods: retrospective study included 29 infants diagnosed as biliary atresia (ba). they were subjected to modified kpe. two subgroups were present. group a included 16 infants and had kpe. group b included 13 infants and had the assumed modification. wider dissection of fibrous portal plate was considered in both groups. after completion of kpe, the jejunal loop anchored to glisson capsule of liver at porta hepatis in group b.

Eligibility criteria:
inclusion criteria: * infants with biliary atresia diagnosed and treated before 60th day of age exclusion criteria: * infants older than 60 days

Keywords: biliary atresia kasai portoenterostomy modified cholangitis